Embedded within a hospital environment allowing immediate access to high-end medical expertise and extensive patient recruitment as well as a high quality imaging fleet, Nancyclotep, in collaboration with the University Hospital of Nancy, have led to more than a hundred clinical studies since 2009.
There are approximately 30 clinical studies currently underway.
Nancyclotep has created optimal / effective clinical validation conditions in order to meet the needs of industry:
A single interlocutor.
The establishment of a quality control procedure and accreditation procedures. Nancyclotep is accredited for its PET/CT equipment by the EANM at the European level, and by the CATI at the French level, as well as by various foreign CROs (Clinical Research Organizations) specialized in medical imaging.
A project manager for each project in charge of compliance with Good Clinical Practice (GCP) standards.
The management of a centralized visualization device. Nancyclotep and its technical team provide, in the context of multicenter trials with centralized visualization of PET exams, the management of the transfer of exams on a dedicated visualization and assessment platform (KEOSYS) as well as the quality control of these examinations on behalf of the French Nuclear Medicine Society (SFMNnet).
Compliance with regulatory constraints. Nancyclotep masters all current implementations to meet the regulatory constraints imposed by the French authorities, the ASN (Nuclear Safety Authority), the ANSM (National Agency for Drug Safety) and the CPP (Committees for the Protection of Persons).
Owing to its technical, methodological and regulatory expertise in the field of interventional research on human subjects, Nancyclotep is proactive in the design, development and implementation of clinical trials in the Nuclear Medicine department of the University Hospital of Nancy.
The obtaining of upcoming authorizations for the handling of new radioelements such as Lutetium-177 and Actinium-225 (177Lu, 225Ac) will allow the recruitment of patients eligible for clinical studies involving innovative radiotherapeuticals.